Natco Pharma Limited Job Vacancy for Regulatory Affairs Department
Vacancy for our Regulatory Affairs Department (API) for our API R&D Centre @ Sanath Nagar, Hyderabad.
Education: M.Sc (Organic Chemistry)
Experience : 3 – 6 yrs
(Preferable Male Candidates)
Coordination with cross functional teams for the deficiencies which are received from various regulatory agencies & ensuring responses are submitted for a speed in approval.
Evaluation of KSM and vendor documents
Complete submissions to FDA, EU regulatory entities.
Create and maintain product EU technical files.
Preparation of organized and scientifically valid DMF/Dossier submission to various agencies as per requirement.
Assessing and filing amendments/variations to the information (which may be related to manufacture, control, stability studies etc) in DMF/ASMF/Dossier of particular API with the Regulatory agencies
ROS evolution of starting material, intermediate and drug substances.
Involve in the designing of specification for starting material, Intermediates and drug substances
Interested candidates are requested to share the profiles to Mail id: jhansi@natcopharma.co.in
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